BEFORE SHORTAGE OF FLU VACCINE, MANY WARNINGS

This article was reported by Denise Grady, Lizette Alvarez, Gardiner Harris and Andrew Pollack and was written by Ms. Grady.

Published: October 17, 2004

Scene by disheartening scene, the spectacle of a severe shortage of flu vaccine is unfolding around the country.

Last week, elderly and chronically ill people waited in line for hours to get flu shots; some were turned away. One died, after hitting her head when she passed out or fell while waiting. Price gougers demanded $800 for $60 vials of vaccine. States threatened to fine or jail doctors and nurses who gave shots to anyone not in the high-risk groups. Congress, the Justice Department and the Securities and Exchange Commission began investigations into how the nation has been left, on the brink of flu season, with half the flu vaccine it needs.

The shortage caught many Americans by surprise, but it followed decades of warnings from health experts who said the nation's system for vaccine supply and distribution was growing increasingly fragile.

''We're in the middle of a crisis that could have been averted,'' said Dr. Irwin Redlener, associate dean of the Mailman School of Public Health at Columbia University and director of its national center for disaster preparedness.

In particular, public health experts have long cautioned against the country's dependence on a few vaccine makers, and yet this has become standard practice. There are now only two major manufacturers for the nation's supply of flu vaccine, and at least a half-dozen other vaccines are made by single suppliers. Britain, by contrast, has spread its order for flu vaccines among five suppliers, precisely to avoid the kind of predicament America now faces.

In recent years there have been many significant disruptions of vaccine supplies. Between November 2000 and May 2003, there were shortages of 8 of the 11 vaccines for childhood diseases in the United States, including those for tetanus, diphtheria, whooping cough, measles, mumps and chicken pox. There have been flu vaccine shortages or miscues for four consecutive years.

In recent decades, many drug companies in the United States abandoned the manufacture of vaccines, saying that they were expensive to make, underpriced and not profitable enough. Flu vaccine can be a particular gamble, because the demand for it varies from year to year and companies throw away what they do not sell because a new vaccine must be made each year to deal with changing strains of the virus. Some companies dropped out because of lawsuits, and others because they determined that it would not pay to retool aging vaccine plants to meet regulatory standards.

The government did little to stop companies from quitting the business, and in some cases may have created policies that made matters worse. A report last year by the Institute of Medicine, a unit of the National Academy of Sciences, noted that 30 years ago, 25 companies made vaccines for the United States, whereas today there are 5.

Dr. Jesse Goodman, director of the branch of the Food and Drug Administration that oversees vaccines, acknowledged that it was risky to have only one or two suppliers for products so essential for public health. ''The more quality, licensed manufacturers we have, the more protected the system is if a problem occurs with one of them,'' he said.

The heart of the problem, experts say, may be that no one person or agency is in charge of making sure the United States has an adequate vaccine supply. The production, sale and distribution of vaccines, particularly those for flu, are handled almost entirely by pharmaceutical companies.

When companies began to leave the market, Dr. Redlener said, government health officials should have tried to find ways to keep them in it, in order to avoid shortages and dependence on too few suppliers.

Bill Pierce, a spokesman for Health and Human Services Secretary Tommy G. Thompson, acknowledged that vaccine supplies in the United States were vulnerable to disruptions. But he blamed years of neglect by previous administrations.

Mr. Thompson has made fixing the system a priority, Mr. Pierce said. The administration has increased financing for handling the flu, including considerably more money for research into more reliable manufacturing techniques for vaccines, and has also explored measures to lure more manufacturers into making flu vaccine, he said.

The government cannot force companies to make vaccines, however. Legally, of course, manufacturers are free to quit the business. But, Dr. Redlener said, ''When there is a vital public health issue at stake here like protection against the flu, that's not good enough.'' The government, he added, ''had an ethical obligation to work with manufacturers.''

A Shortage and an Apology

Influenza can be dangerous. It kills 36,000 people a year in the United States and puts about 200,000 in the hospital. The very old, the very young and people with chronic illnesses are particularly likely to become severely ill from the flu, and in recent years health officials have recommended wider use of the vaccine. The message seems to be reaching the public: demand for the vaccine has grown greatly in the past decade, to more than 85 million doses a year in 2003 from around 20 million in the early 90's.Just as people had begun to appreciate the value of flu shots, the worst vaccine shortage yet struck. It was announced on Oct. 5, when bacterial contamination led British regulators to suspend the license of a vaccine plant in Liverpool on which the United States was depending for 46 million to 48 million doses, nearly half of America's supply. The plant is owned by Chiron, an American company.